Measure | Screening | Baseline | Week 1 | Week 2 | Week 4 | Week 8 | Week 12 | Week 24 | Week 36 | Early withdrawal |
---|---|---|---|---|---|---|---|---|---|---|
Depression and quality of life | ||||||||||
 PHQ-9 | X |  |  |  |  |  |  |  |  |  |
 Suicide subscale of MINI | X |  |  |  |  |  |  |  |  |  |
 CSI-D | X |  |  |  |  |  |  |  |  |  |
 HAMD-17 | X | X |  |  | X | X | X | X | X | X |
 QIDS-SR16 |  | X | X | X | X | X | X | X | X | X |
 BDI-II |  | X | X | X | X | X | X | X | X | X |
 GDI-SR |  | X |  |  | X | X | X | X | X | X |
 MLHFQ |  | X |  |  | X | X | X | X | X | X |
Cardiac function | ||||||||||
 NYHA staging | X | X |  |  | X | X | X | X | X | X |
 6-min walk test | X | X |  |  | X | X | X | X | X | X |
 NT-proBNP |  | X |  |  |  |  | X |  | X | X |
 Ultrasound cardiogram |  | X |  |  |  |  | X |  | X | X |
Clinical records and logs | ||||||||||
 Clinical symptoms and signs | X | X |  |  | X | X | X | X | X | X |
 Vital signs | X | X |  |  | X | X | X | X | X | X |
 Concomitant medications |  | X |  |  | X | X | X | X | X | X |
 Adverse events log |  |  | X | X | X | X | X | X | X | X |